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Lovaza plus atorvastatin · 2 trials · 2 indications
Primary Specific Aim To determine the effects of omega-3 fatty acid supplementation on urine protein excretion and surrogate markers of kidney injury including: serum beta-microglobulin and cystatin C (biomarkers of GFR) and urine neutrophil gelatinase-associated lipocain (NGAL a.k.a. lipocalin-2), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) (biomarkers of tubular reabsorption impairment and inflammation).
Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.
| Arm | Type | Description |
|---|---|---|
| Lovaza | EXPERIMENTAL | 4 grams per day |
| atorvastatin arm | ACTIVE_COMPARATOR | atorvastatin + placebo |
| Lovaza arm | EXPERIMENTAL | Lovaza + atorvastatin |
| Name | Type | Description |
|---|---|---|
| Lovaza (fish oil) | DIETARY_SUPPLEMENT | 4 grams per day |
| Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin | DRUG | Lovaza + atorvastatin |
| atorvastatin | DRUG | atorvastatin + placebo |
Inclusion Criteria: * Participants have a diagnosis of diabetes (either oral medication or diet controlled) * Have an average systolic blood pressure (SBP) \<150 and diastolic blood pressure (DBP) \<90 mmHg * Have quantified proteinuria -- urine albumin/creatinine ratio of \> 17 mg/g (men) and \>25...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Lovaza is an investigational omega-3 fatty acid supplement being studied for use in diabetes, specifically for diabetes-related kidney disease. It is in Phase 3 clinical development. The drug is being evaluated for its potential effects on kidney health in patients with diabetes.
Lovaza is being developed by GSK plc, a global biopharmaceutical company. GSK trades on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate Lovaza's safety and efficacy for diabetes-related kidney disease.
Lovaza is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for Lovaza has been completed, and the drug is still undergoing clinical evaluation for its potential use in diabetes.
Lovaza has one completed Phase 3 clinical trial registered under NCT01092390, titled "Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease." The trial enrolled 31 participants in the United States and was a randomized, double-blind study without a control group.
Lovaza is an omega-3 fatty acid supplement. It is being studied for its potential benefits in diabetes-related kidney disease. The drug is a formulation of omega-3 fatty acids, which are commonly found in fish oil. Lovaza is currently in Phase 3 clinical development for this indication.